Label: WOMENS GENTLE LAXATIVE- bisacodyl tablet, coated
- NDC Code(s): 55315-326-01
- Packager: FRED'S, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient (in each enteric coated tablet)
Bisacodyl 5 mgClose
for gentle, overnight relief of occasional constipation (irregularity)
this product generally produces bowel movement in 6 to 12 hours
Ask a doctor before use if you have
sudden change in bowel movements that persist over a period of 2 weeks
When using this product
do not use for a period longer than 1 week unless directed by a doctor
you may experience abdominal discomfort, faintness and cramps
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
do not chew or crush tablets
do not take within 1 hour after taking an antacid or milk
adults and children over 12 years of age oral dosage is 1 to 3 tablets in a single or divided daily dose children 6 to under 12 years of age oral dosage is 1 tablet in a single daily dose children under 6 years of age ask a doctor
- Other information
store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
protect from moisture
see end flap for expiration date and lot number
- Inactive ingredients
acacia, black iron oxide, calcium carbonate, carnauba wax, corn starch, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, lactose, magnesium stearate, methylparahydroxy benzoate, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparahydroxy benzoate, shellac glaze, silica, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrateClose
- Principal Display Panel
Bisacodyl 5 mg
Gentle, Dependable Overnight Relief
30 Enteric Coated Tablets
Tested Against The Active Ingredient In: CORRECTOL®*
*This product is not manufactured or distributed Schering-Plough Healthcare Products, owner of the registered trademark Correctol®.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
- INGREDIENTS AND APPEARANCE
WOMENS GENTLE LAXATIVE
bisacodyl tablet, coated
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55315-326 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISACODYL (BISACODYL) BISACODYL 5 mg Inactive Ingredients Ingredient Name Strength ACACIA FERROSOFERRIC OXIDE CALCIUM CARBONATE CARNAUBA WAX D&C RED NO. 27 FD&C BLUE NO. 2 FD&C YELLOW NO. 6 HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOLS Polyvinyl Acetate Phthalate POVIDONES PROPYLENE GLYCOL SODIUM ALGINATE SODIUM BENZOATE SODIUM BICARBONATE STEARIC ACID SUCROSE TALC TITANIUM DIOXIDE TRIACETIN TRIETHYL CITRATE Product Characteristics Color PINK Score no score Shape ROUND Size 11mm Flavor Imprint Code 44;326 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55315-326-01 1 in 1 CARTON 1 30 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 02/12/2005 Labeler - FRED'S, INC. (005866116) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(55315-326) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(55315-326)